Knobbe/Martens: Intellectual Property Law

Cryoablation Competition Heats Up

By Michael P. Burns, Ph.D. December 11, 2018

Atrial fibrillation (AF), a common heart rhythm disorder, is often treated with cardiac ablation. Cardiac ablation uses RF (heating) or cryothermal (cooling) energy to scar the areas of the heart muscle that are responsible for the abnormal heart rhythm. Abbott Laboratories, Boston Scientific, and Biosense Webster (a subsidiary of Johnson & Johnson), each offer RF ablation catheters. According to one analyst, however, Medtronic is the first company to launch a cryoablation device and currently has reign over the cryoablation market. Recent developments suggest competition in cryoablation is now ramping up.

“The cryoablation market is set for disruption as Adagio Medical, Boston Scientific and a number of other smaller companies enter the space to challenge the market dominance of Medtronic’s devices.” -Sheryl Tang, senior analyst for medical devices at GlobalData.

GlobalData estimates cryoablation catheters make up approximately 27% of the global electrophysiology ablation catheters market, with the cryoablation catheter market growing at a Compound Annual Growth Rate (CAGR) of 5%. GlobalData expects small companies with successful devices in the cryoablation space to be prime acquisition targets for large companies looking to obtain a place in the cryoablation market and to secure a stronger position in the wider electrophysiology ablation market.

Laguna Hills, California-based Adagio Medical, Inc., appears to be one such small company with a cryoablation device. The company recently announced that it successfully treated its first patients with its One Shot+™ catheter. Adagio Medical describes its cryoablation platform as using continuous and uninterrupted flow of the cryogen through the catheter, allowing ultra-low temperature cryoablation catheters with diameters smaller than  2 millimeters.

In July of this year, Boston Scientific announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held company developing a single-shot cryoablation platform for the treatment of AF. According to a recent article, the Cryterion cryoablation system uses a balloon catheter, mapping catheter, and steerable sheath. The Cryterion cryoablation system is not available for sale. However, a clinical study of the Cryterion cryoablation system is reportedly being conducted in Europe, with a CE Mark submission expected in early 2019. Boston Scientific plans to submit an investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA), with patient enrollment expected to begin in 2019.

It remains to be seen whether Biosense Webster or Abbott Laboratories has interest in acquiring a company in the cryoablation space. If either company decides to do so, Adagio Medical may be a target for acquisition.

Meet the Knobbe Martens Attorneys

Cryoablation Competition Heats Up
Michael Burns, Ph.D. focuses on protecting and commercializing his client's inventions within the mechanical, medical device, and life sciences industries. He focuses on patent...
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